Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss
Comparing the Effect of Intra-Umbilical Versus Intravenous Oxytocin During Third Stage of Labor on Mean Blood Loss
The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth.
The main question this study aims to answer is:
Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin?
Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups.
Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered.
In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery.
Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Punjab Province
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Multan、Punjab Province、パキスタン、60000
- CMH Multan Institute of Medical Sciences
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Gestational age 36 - 42 weeks (on LMP)
- In spontaneous labour
Exclusion Criteria:
- Chronic hypertension
- Pre-eclampsia
- Multiple pregnancies
- Preterm or postdates pregnancy
- Previous cesarean section
- Diabetes (chronic and gestational)
- Fetal macrosomia
- History of bleeding / clotting disorder
- History of anti-coagulation heparin / warfarin therapy
- Non-reassuring cardiotocograph or poor progress of labour
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Intravenous Oxytocin
Women in this group will receive 10 IU oxytocin administered intravenously at the delivery of the anterior shoulder of the baby during the third stage of labor.
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10 IU oxytocin diluted in normal saline administered slowly via intravenous route at the time of delivery of the anterior shoulder to facilitate uterine contraction and reduce blood loss.
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実験的：Intraumbilical Oxytocin
Women in this group will receive 10 IU oxytocin administered through the umbilical vein after delivery of the baby during the third stage of labor.
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10 IU oxytocin diluted in 10 mL normal saline injected into the umbilical vein approximately 2 cm from the introitus after delivery of the baby, with the solution gently milked toward the placental insertion to promote placental separation and reduce blood loss.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery
時間枠：From delivery of the baby until 24 hours postpartum
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The average amount of blood lost after delivery will be measured in milliliters.
Blood loss will be collected in a kidney tray immediately after delivery and quantified using a graduated cylinder.
Additional blood loss during the first 24 hours postpartum will be measured using pre-weighed sanitary pads (1 gram weight increase = 1 mL blood loss).
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From delivery of the baby until 24 hours postpartum
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協力者と研究者
捜査官
- スタディチェア：Nidda Y Assistant Professor, FCPS、CMH Multan Institute of Medical Sciences
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- U1111-1339-8043
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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